LIST OF DRUGS BANNED FOR MARKETING IN INDIA

The Government of India vide notifications published in the Gazette of India vide G.S.R. No. 578 (E) dated 23/07/1983 and subsequent amendments, made under Section 26 A of Drugs and Cosmetics Act, 1940 has prohibited the manufacture, sale and distribution of the following categories of fixed dose combinations which do not have any therapeutic justification or are likely to involve risk to human beings:

(48) Antidiarrhoeal formulations containing Neomycin or Streptomycin or Dihydrostreptomycin including their respective salts or esters.

(49) Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing Diphenoxylate or Atropine or Belladona including their salts or esters or metabolites Hyoscyamine or their extracts or their alkaloids.

(50) Liquid Oral antidiarrhoeals or any other dosage form for pediatric use containing halogenated hydroxyquinolines.

(51) Fixed dose combination of antidiarrhoeals with electrolytes.

G.S.R. No. 57 (E) dtd 07-02-1995

(43) Patent and Proprietary Oral Rehydration Salts other than those conforming to the following parameters:

(a) Patent and Proprietary Oral Rehydration Salts on reconstitution to one litre shall contain:- Sodium - 50 to 90 millimoles. Total osmolarity - 240 - 290 milli osmoles. Dextrose : Sodium molar ratio - Not less than 1:1 and not more than 3:1(b) Patent and Proprietary cereal based Oral Rehydration Salts on reconstitution to one litre shall contain :- Total osmolarity - Not more than 2900 milli osmoles. Precooked rice- Equivalent to not less than 50 gm and not more than 80 gm as total replacement of Dextrose.(c) Patent and Proprietary Oral Rehydration Salts (ORS) may contain aminoacids in addition to Oral Rehydration Salt conforming to the parameters specified above and labeled with the indication for "Adult Choleratic Diarrhoea" only.(d) Patent and Proprietary Oral Rehydration Salts shall not contain Mono or Polysaccharides or saccharin sweetening agent.

405 (E) dtd 03-06-1996]Clarification : Fixed dose combination of Analgin with any other drug other than antispasmodics were banned by the Government of India vide G.S.R. No. 633(E), dated 13.09.1995. However, the Drug Action Forum contended before the Supreme Court that the preparations of Analgin and antispasmodics should also be banned. Dr. J.S. Bajaj, being directed by the court, submitted his report supporting these contentions.
On 17th Dec. 1996, a learned additional Solicitor submitted that the Central Government has decided that all State/U.T. Drug Licensing Authorities will be given directions by the Government under Section 33-P of the Drugs and Cosmetics Act, to suspend manufacturing licenses of all fixed dose formulations of Analgin including Analgin with Antispasmodics till further notice. Accordingly, the Government of India, under letter dated 17th Dec.1996, issued such directives. In view of the above directives, the manufacture, sale and distribution of fixed dose combinations of Analgin and antispasmodics is prohibited.

(55) Fixed dose combination of dextropropoxyphene with any other drug other than anti-spasmodics and/or non-steriodal anti-inflammatory drugs (NSAIDS).

(56) Fixed dose combination of a drug, standards of which are prescribed in the Second Schedule to the said Act with an Ayurvedic, Siddha or Unani drug.

G.S.R. No. 498 (E) dtd 11-7-2014 (with effect from 11-7-2014)

Fixed dose combination of Flupenthixol and Melitracen for human use

G.S.R. No. 378 (E) dtd 18-6-2013

(revoked allowing the use of drug with condition “The drug is indicated for Severe pain or pain due to tumor and also for bringing down temperature in refractory cases when other antipyretics fail to do so.” vide G.S.R. No.86(E) dtd 13-02-2014)

G.S.R. No. 379 (E) dtd 18-6-2013 (with effect from 18-6-2013)

(94) Pioglitazone and all formulations containing Pioglitazone for human use.

G.S.R . 29 (E) dtd 17-01-2014 (with effect from 17-01-2014)

(95) The drug oxytocin shall be manufactured for sale or for distribution or sold in the manner specified below, in addition to the provisions contained in the Act and Rules made thereunder, namely:-

(i) The manufacturers of bulk oxytocin drug shall supply the active pharmaceutical drug only to the manufacturers licensed under the Drugs and Cosmetics Rules, 1945 for manufacture of formulations of the said drug. (ii) The formulations meant for veterinary use shall be sold to the veterinary hospitals only.

S. O. 1853 (E) dtd 08-06-2017 (with effect from 08-06-2017)

S. O. 1854 (E) dtd 08-06-2017 (with effect from 08-06-2017)

(99) Fixed dose combination of Glucosamine + Ibuprofen for human use.

S. O. 1855 (E) dtd 08-06-2017 (with effect from 08-06-2017)

(100) Fixed dose combination of Etodolac + Paracetamol for human use.

In addition to the above-mentioned drugs, manufacture and sale of all Cosmetics and all Ayurvedic Drugs licensed as toothpaste, tooth powders containing tobacco have been prohibited under G.S.R. 443 (E) and 444(E) dated 30.4.92